Quality Assurance review and analysis of project documentation deliverables
Regulatory Compliance and Risk Assessments, including for SOX, GMP, GLP, GCP, PDMA, 21 CFR Part 11
Independent internal and external vendor audits, both IT and GxP
Development of Standardized Regulatory Practices and
Processes leading to reductions in the "validation
life cycle"
Independent pre-audit inspections and reviews
Facility Qualifications - Manufacturing sites as
well as IT Data Centers
Establishment of Quality Management Systems